Bone screw retaining system with pinned retainer

ABSTRACT

A bone screw retention system is provided for a plate which defines a plurality of transversely extending bores that are configured to receive a bone screw for engaging the plate to the cervical spine. The retention member has a body and two legs extending therefrom the body. The legs are moveable from a first position to a second position, thereby enabling or preventing movement of a bone screw therein the bores.

CONTINUITY DATA

This application claims priority to and the benefit of U.S. ProvisionalPatent Application 61/554,972 filed on Nov. 2, 2011, and is acontinuation in part of U.S. patent application Ser. No. 12/791,899,filed on Jun. 2, 2010 and which claims priority to U.S. Utilityapplication Ser. No. 12/738,217, filed on July 25, 201, U.S. ProvisionalPatent Application 61/029,771, filed on Feb. 18, 2008, and U.S.Provisional Patent Application 60/980,356, filed on Oct. 16, 2007, allof which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to surgical procedures, mostparticularly for use in fixation of the cervical spine. Moreparticularly, the invention pertains to a bone screw retaining systemfor use in a plating system for use in a system for anteriorly fixatingat least two adjacent bones in the human spine and a removal system foruse in removing screws from the plate system.

BACKGROUND OF THE INVENTION

As with any bony structure, the spine is subject to various pathologiesthat compromise its load bearing and support capabilities. The spine issubject to degenerative diseases, the effects of tumors and, of course,fractures and dislocations attributable to physical trauma. In the past,spinal surgeons have tackled the thorny problems associated withaddressing and correcting these pathologies using a wide variety ofinstrumentation and a broad range of surgical techniques. In spinalsurgeries, the fusion of two or more vertebral bodies is required. Theuse of elongated rigid plates has been helpful in the stabilization andfixation of the lower spine, most particularly the thoracic and lumbarspine while awaiting the fusion of the two vertebral bodies.

The cervical spine can be approached either anteriorly or posteriorly,depending upon the spinal disorder or pathology to be treated. Many ofthe well known surgical exposure and fusion techniques of the cervicalspine are described in Spinal Instrumentation, edited by Drs. Howard Anand Jerome Cotler. This text also describes instrumentation that hasbeen developed in recent years for application to the cervical spine,most frequently from an anterior approach.

The anterior approach to achieving fusion of the cervical spine hasbecome the most popular approach. During the early years of cervicalspine fusion, the fusions were performed without internalinstrumentation, relying instead upon external corrective measures suchas prolonged recumbent traction, the use of halo devices or Minervacasts, or other external stabilization. However, with the advent of theelongated plate customized for use in the cervical spine, platingsystems have become the desired internal stabilization device whenperforming stabilization operations.

It has been found that many plate designs allow for a uni-corticaly orbi-corticaly intrinsically stable implant. It has also been found thatfixation plates can be useful in stabilizing the upper or lower cervicalspine in traumatic, degenerative, tumorous or infectious processes.Moreover, these plates provide the additional benefit of allowingsimultaneous neural decompression with immediate stability.

During the many years of development of cervical plating systems,particularly for the anterior approach, various needs for such a systemhave been recognized. For instance, the plate must provide strongmechanical fixation that can control movement of each vertebral motionsegment in six degrees of freedom. The plate must also be able towithstand axial loading in continuity with each of the three columns ofthe spine. The plating system must be able to maintain stress levelsbelow the endurance limits of the material, while at the same timeexceeding the strength of the anatomic structures or vertebrae to whichthe plating system is engaged.

Further plating systems also typically require the thickness of theplate to be small to lower its prominence, particularly in the smallerspaces of the cervical spine. Additionally, the screws used to connectthe plate to the vertebrae must not loosen over time or back out fromthe plate. This requirement, that the bone screws do not loosen overtime or back out from the plate, tends to complicate implantation ofknown plating systems. Such bone screw retention systems generallyensure that the bone screws placed into the vertebrae through theplating system do not back out voluntarily from the plate, but oftenrequire an additional locking step to secure the screw to the plate.Current systems without the extra step have been less than optimal,overly difficult to perform, with inadequate results.

On the other hand, while the plate must satisfy certain mechanicalrequirements, it must also satisfy certain anatomic and surgicalconsiderations. For example, the cervical plating system must minimizethe intrusion into the patient and reduce the trauma to the surroundingsoft tissue. It is known that complications associated with any spinalprocedure, and most particularly within the tight confines of cervicalprocedures, can be very devastating, such as injury to the, spinal cordor vertebral arteries. It has also been found that optimal platingsystems permit the placement of more than one screw in each of theinstrumented vertebrae.

More specifically, it is known that bone screws can be supported in aspinal plate in either a rigid or semi-rigid fashion. In a rigidfashion, the bone screws are only permitted micro-motion with nosignificant angular movement relative to the plate. In the case of asemi-rigid fixation, the bone screw can move somewhat relative to theplate during the healing process of the spine. It has been suggestedthat semi-rigid fixation is preferable for the treatment of degenerativediseases of the spine. In cases where a graft is implanted to replacethe diseased vertebral body or disk, the presence of a screw capable ofsome angulation or translation ensures continual loading of the bonegraft. This continual loading avoids stress shielding of the graft,which in turn increases the rate of fusion and incorporation of the bonegraft into the spine.

Similarly, rigid screw fixation is believed to be preferable in thetreatment of tumors or trauma to the spine, particularly in the cervicalregion. It is believed that tumor and trauma conditions are bettertreated in this way because the rigid placement of the bone screwspreserves the neuro-vascular space and provides for immediate rigidstabilization to an area typically more unstable. It can certainly beappreciated in the case of a burst fracture or large tumorousdestruction of a vertebra that immediate stabilization and preservationof the vertebral alignment and spacing is essential. On the other hand,the semi-rigid fixation is preferable for degenerative diseases becausethis type of fixation allows for a dynamic construct. In degenerativeconditions, a bone graft is universally utilized to maintain either thedisc space and/or the vertebral body itself. In most cases, the graftwill settle or be at least partially resorbed into the adjacent bone. Adynamic construct, such as that provided by semi-rigid bone screwfixation, will compensate for this phenomenon.

Furthermore, known plating systems often do not permit sufficientangular freedom for bone screws relative to the plate. Generally, knownplating systems have defined bores through which bone screws are placedat a predefined angle. Therefore, the operating surgeon often does nothave freedom to insert the bone screws into the vertebrae as to best fitthe anatomy of the individual patient. While some known systems dopermit bone screw angulation, they typically are not adapted to be usedwith an easy-to-use bone screw retaining mechanism.

It remains desirable in the art to provide a bone screw retaining systemand a bone screw removal device for use with a plating system thataddresses the limitations associated with known systems, including butnot limited to those limitations discussed above.

SUMMARY OF THE INVENTION

In accordance with the purposes of this invention, as embodied andbroadly described herein, this invention, in one aspect, relates to abone screw retention system that includes an implant having a plate,which defines a plurality of transversely extending bores that areconfigured to receive a bone screw for engaging the plate to thecervical spine. One or more retention members, having an elliptical,oval, rectangular, square, or other shape, can be positioned therein acavity of the plate such that portions of the retention member(s) extendinto a portion of an upper region of each bore to retain a bone screwtherein.

In another aspect, a bone screw removal device is provided, having atleast one tongue member configured to selectively displace the one ormore retention members to allow the bone screw to be removed from therespective bore. In one aspect, the bone screw removal device includesan outer sleeve having at least one notch extending from a lower surfaceof the outer sleeve, and an inner sleeve having at least one tonguemember that has a protrusion extending from a lower portion of thetongue member. In a further aspect, the inner sleeve is configured to bepositioned within the outer sleeve with the tongue member and protrusionof the inner sleeve longitudinally aligned with the notch of the outersleeve.

In yet another aspect, a method is provided for removing a bone screwfrom a bone screw retention system utilizing exemplary bone screwremoval devices as described herein.

Additional advantages of the invention will be set forth in part in thedescription which follows, and in part will be obvious from thedescription, or may be learned by practice of the invention. Theadvantages of the invention will be realized and attained by means ofthe elements and combinations particularly pointed out in the appendedclaims. It is to be understood that both the foregoing generaldescription and the following detailed description are exemplary andexplanatory only and are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

FIG. 1A is a top plan view of an exemplary bone screw retention systemcomprising a plate having a plurality of bores therein and a pluralityof bone screws seated therein the bores.

FIG. 1B is a perspective view of the bone screw retention system of FIG.1A, showing a plurality of bone screws seated therein the bores of theplate and positioned at desired angles relative to the plate.

FIG. 2A is a top plan view of the exemplary bone screw retention systemof FIG. 1A having a plurality of elliptical ring-shaped retentionmembers.

FIG. 2B is a partial top plan view of an elliptical ring-shapedretention member of FIG. 2A in a first relaxed position, in whichportions of the retention member extend over a portion of the upperregion of a bore of the plate.

FIG. 2C is a partial side cross-sectional view, taken along line A-A ofFIG. 2B, of a bone screw positioned therein a bore of the plate of thebone screw retention system and retained therein by an ellipticalring-shaped retention member in the first relaxed position.

FIG. 2D is a partial top plan view of an elliptical ring-shapedretention member of FIG. 2A in a second open position allowing the bonescrew to be removed from the bore.

FIG. 2E is a partial side cross-sectional view, taken along line A-A ofFIG. 2D, of a bone screw positioned therein a bore of the plate of thebone screw retention system and an elliptical ring-shaped member in thesecond open position allowing the bone screw to be removed from thebore.

FIG. 3A is a top plan view of the exemplary bone screw retention systemof FIG. 1A having a respective rectangular retention member positionedtherein each of the bores of the plate.

FIG. 3B is a partial top plan view of a rectangular retention member ofFIG. 3A in a first relaxed position in which two sides of therectangular retention member extend over a portion of the upper regionof a bore of the plate.

FIG. 3C is a partial top plan view of the rectangular retention memberof FIG. 3B in a second open position, allowing the bone screw to beremoved from the bore.

FIG. 4A is a top plan view of the exemplary bone screw retention systemof FIG. 1A having a respective rectangular dual retention memberpositioned between a pair of opposing bores of the plate.

FIG. 4B is a partial top plan view of a rectangular dual retentionmember of FIG. 4A in a first relaxed position in which one side of therectangular dual retention member extends over a portion of the upperregion of a first bore of the plate, and an opposing side extends over aportion of the upper region of a second bore of the plate.

FIG. 4C is a partial top plan view of the rectangular dual retentionmember of FIG. 4B in a second open position, allowing the first andsecond bone screws to be removed from the bore.

FIG. 5A is a perspective view of an inner sleeve of a bone screw removaldevice.

FIG. 5B are perspective views of a bone screw removal device showing,from left to right, the inner sleeve of FIG. 5A positioned within anouter sleeve, the inner sleeve in a first raised position with a tonguemember of the inner sleeve retained within the outer sleeve; and theinner sleeve in a second, lowered position with a tongue memberprotrusion of the inner sleeve extending into a notch of the outersleeve.

FIG. 6 are front elevational views of, from left to right, the innersleeve of the bone screw removal device of FIG. 5A; the inner sleevepositioned within the outer sleeve in the first, raised position; andthe inner sleeve in the second, lowered position with the tongue memberof the inner sleeve extending into the notch of the outer sleeve.

FIG. 7A are front cross-sectional views of the bone screw removal deviceshowing the inner sleeve in the first, raised position (shown on theleft) and the second, lowered position (shown on the right).

FIG. 7B are side cross-sectional views of the bone screw removal deviceshowing the inner sleeve in the first, raised position (shown on theleft) and the second, lowered position (shown on the right).

FIG. 7C are side elevational views of, from left to right, the innersleeve of the bone screw removal device of FIG. 5A, showing the guideslot formed therein the side of the inner sleeve; the inner sleevepositioned within the outer sleeve in the first, raised position; andthe inner sleeve in the second, lowered position with the tongue memberof the inner sleeve extending into the notch of the outer sleeve.

FIG. 8A is a side cross-sectional view of a bone screw removal deviceshowing an inner sleeve having a pair of opposing tongue members, theinner sleeve positioned within an outer sleeve in a first, raisedposition.

FIG. 8B is a side cross-sectional view of the bone screw removal deviceof FIG. 8A showing the inner sleeve positioned within the outer sleevein a second, lowered position.

FIG. 8C are side elevation views of, from left to right, the innersleeve of the bone screw removal device of FIG. 8A showing the pair ofopposing tongue members and a guide slot formed therein the side of theinner sleeve; the inner sleeve positioned within the outer sleeve in thefirst, raised position; and the inner sleeve in the second, loweredposition with tongue member protrusions of the inner sleeve extendinginto respective notches of the outer sleeve.

FIG. 9 illustrate exemplary downward movement of an inner sleeve withinan outer sleeve, the tongue member protrusion of the inner sleeveextending therethrough the notch of the outer sleeve and pushing out aretention member as the inner sleeve is lowered from a first raisedposition (shown on the left), through an intermediate position (middle)to a second lowered position (shown on the right).

FIG. 10 illustrate exemplary downward movement of an inner sleeve havinga pair of opposing tongue members, the tongue member protrusionsextending therethrough a pair of opposing notches of the outer sleeveand pushing out retention members as the inner sleeve is lowered from afirst raised position (shown on the left), through an intermediateposition (middle), to a second lowered position (shown on the right).

FIG. 11 illustrate exemplary downward movement of an inner sleeve withinan outer sleeve, the tongue member protrusion of the inner sleeveextending therethrough the notch of the outer sleeve and pushing out aretention member, and the removal of a bone screw with a removal tool.

FIG. 12 are side cross-sectional view of a bone screw removal devicebeing used to remove a bone screw retained by a rectangular retentionmember.

FIG. 13 illustrate exemplary use of a removal tool to push out at leastone tongue member, thereby pushing out at least one retention member.

FIG. 14A is a perspective view of a main sleeve of an exemplary bonescrew removal device.

FIG. 14B is a perspective view of an exemplary bone screw removaldevice, showing a removal sleeve positioned around the main sleeve ofFIG. 14A.

FIG. 14C is a front view of the exemplary bone screw removal device ofFIG. 14B.

FIG. 14D is a side view of the exemplary bone screw removal device ofFIG. 14B, showing a tongue member of the removal sleeve in a first,resting position.

FIG. 14E is a side view of the exemplary bone screw removal device ofFIG. 14B, showing the tongue member in a second, in-use position.

FIG. 15 is a top plan view of a fourth embodiment for a retentionmember, having a body, two legs, and defining a retention bore.

FIG. 16 is a partial top plan view of the retention member of FIG. 15 ina first relaxed position, in which portions of the legs of the retentionmember extend over a portion of the upper region of a bore of the plate.

FIG. 17 is a partial side cross-sectional view, taken along line 17-17of FIG. 16, of a bone screw positioned therein a bore of the plate ofthe bone screw retention system and retained therein by the retentionmember of FIG. 15 in the first relaxed position.

FIG. 18 is a partial top plan view of the retention member of FIG. 15,in a second expanded position allowing the bone screw to be removed fromthe bore.

FIG. 19 is a partial side cross-sectional view, taken along line 19-19of FIG. 18, of a bone screw positioned therein a bore of the plate ofthe bone screw retention system and the retention member of FIG. 15 inthe second expanded position allowing the bone screw to be removed fromthe bore.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention may be understood more readily by reference to thefollowing detailed description of various embodiments of the invention,examples, figures, and their previous and following description.

Before the present system, devices, and/or methods are disclosed anddescribed, it is to be understood that this invention is not limited tothe specific systems, devices, and/or methods disclosed unless otherwisespecified, as such can, of course, vary. It is also to be understoodthat the terminology used herein is for the purpose of describingparticular aspects only and is not intended to be limiting.

As used herein, the singular forms “a,” “an” and “the” include pluralreferents unless the context clearly dictates otherwise. Thus, forexample, reference to a “screw” includes aspects having two or morescrews unless the context clearly indicates otherwise.

Ranges may be expressed herein as from “about” one particular value,and/or to “about” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. Itwill be further understood that the endpoints of each of the ranges aresignificant both in relation to the other endpoint, and independently ofthe other endpoint.

In this specification and in the claims which follow, reference will bemade to a number of terms which shall be defined to have the followingmeanings:

As used herein, the terms “optional” or “optionally” mean that thesubsequently described event or circumstance may or may not occur, andthat the description includes instances where said event or circumstanceoccurs and instances where it does not.

Reference will now be made in detail to various embodiments of thepresent invention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers are usedthroughout the drawings to refer to the same or like parts.

In one embodiment, and referring to FIGS. 1A and 1B, a plate system cancomprise an implant 150, particularly for the spinal column, that canhave a joining member, such as a plate 152, that defines a plurality ofopenings or bores 154, and bone screws 160 capable of being accommodatedin the bores. In a further embodiment, at least one retention member isprovided and is configured for releasably securing the bone screwstherein the bores. The bone screw removal device, in one aspect,provides for the selective removal of the bone screw or screws from theplate at the physician's desire.

In one aspect, the plate 152 defines a plurality of transverselyextending bores 154 that are countersunk at a predetermined distance. Inone exemplary aspect, a head of a bone screw can be configured to beposteriorly displaceable through a bore of the plate from an anteriorsurface 152 a to a posterior surface 152 b of the plate and retainedwithin a portion of the bore between the anterior and posteriorsurfaces. In one aspect, the plate 152 can have a generally elongatedform whose outline generally departs from rectangular due to thepresences of partial lobes or lateral projections at the corners and atthe center sides of the plate, as can be seen in FIG. 1A. Each partiallobe has a rounded outline and, in an exemplary aspect, can define arespective bore. It is, of course, contemplated that other shapes of theplate can be employed.

As noted above, the plate 152 defines a plurality of bores 154 thatextend substantially transverse therethrough the plate between theanterior and posterior surfaces 152 a, 152 b of the plate and that areconfigured for operable receipt of the bone screw(s) 160. In one aspect,the bores extend along a longitudinal axis from the anterior surface tothe bottom, bone-contacting, posterior surface 152 b of the plate. Inone aspect, each bore has an upper region with a first diameter and alower region that includes a seat 156 for the bone screw and aposteriorly extending tubular shaft 158 that extends to an opening onthe posterior surface of the plate, as can be seen in FIG. 2C, forexample. In one aspect, the seat of the bore can have at least a partialspherical shape. In another aspect, the plate comprises a plurality ofpair opposing bores.

In a further aspect, such as illustrated in FIG. 2C, the bone screw 160has a head 162 with a maximum diameter that is smaller than the firstdiameter of the upper region of the bore, which thereby allows the screwhead to pass through that region of the bore. In one example, the bonescrew can be a conventional self-tapping bone screw. It is, of course,contemplated that conventional non self-tapping bone screws can be usedwith the system of the present invention. Further, it is contemplatedthat conventional bone screws with at least partially rotatable headscan be used if a semi-rigid fixation procedure is desired.

According to various aspects, the head 162 of each bone screw 160 cancomprise a complementary tapered section that extends from an upwardlyfacing shoulder surface 164, which is formed by a portion of the head ofthe bone screw, and tapers toward a threaded shank portion 166 of thebone screw. A portion of the bone screw above the upwardly facingshoulder surface 164 of the bone screw is conventionally configured foroperative engagement with a driving tool 150 and has a reduced diameterrelative to the diameter of the shoulder of the head of the bone screw.

In one aspect, the tubular shaft 158 of the bore is configured forcomplementary receipt of the shank of the bone screw such that the bonescrew can be fixed at a predetermined angle with respect to the plate.Alternatively, the bone screw can be fixed at an operator selectedangle, i.e., be angularly displaceable. In one aspect, the taperedsection of the bone screw can be configured for complementary rotatablecontact with an exemplary spherically shaped seat of the bore. It iscontemplated that the tapered section of the bone screw can besubstantially linear or, optionally, substantially hemispherical.Further, the shank of the bone screw can be threaded in any well knownfashion and may include an axial groove to enable the bone screw to beself-boring and self-tapping.

In another aspect, the shaft 158 of the bore can have an operativediameter that is greater than the diameter of the shank 166 of the bonescrew intermediate the head of the bone screw and its distal end. As aresult, the bone screw 160 is angularly displaceable within the shaft ofthe bore between the seat and the posterior surface opening. The bonescrew can thus be tilted within the shaft of the bore relative to thelongitudinal axis of the bore to facilitate positioning the bone screwat a desired location in the bone by advancing the threaded shankportion of the bone screw within the bone at an angle relative to theposterior surface 152 b of the plate. In one aspect, the bone screw 160can be angularly displaced relative to the longitudinal axis of the boreup to an angle of about 20 degrees. Thus, the physician or surgeon has,at his disposal, the freedom to orient the bone screw angularly withrespect to the joining member or plate, which allows him to optimize theanchorage. In one aspect, the bone screw(s) can be rotatably mountedtherein the underlying bone tissue using a conventional screw driver, adrive socket, and the like.

According to various embodiments, a retaining system is provided that isconfigured to secure a bone screw therein a respective bore. In oneaspect, the retaining system comprises at least one elasticallydeformable retention member. In another aspect, the retention member canhave an edge portion. In this aspect, at least a portion of the at leastone retention member can be positioned therein each at least one cavityof the plate such that portions of the at least one retention memberextend into an upper region of each of the bores. In a further aspect,the at least one retention member can be configured to mount therein theat least one cavity and can be configured to be movable between a firstrelaxed position and a second expanded position. In a further aspect,the at least one elastically deformable retention member can comprise aplurality of elastically deformable retention members.

In the first relaxed position, a portion of the edge portion of the atleast one retention member extends inwardly substantially transverse toand toward the longitudinal axis of the respective bore and into theupper region of the bore. As one will appreciate, an effective innerdiameter of the upper region of the bore is decreased in the firstrelaxed position. In another aspect, a portion of the edge portion ofthe at least one retention member extends over portions of the upperregion of a plurality of bores of the plate in the first relaxedposition.

In the second expanded position, portions of the at least one retentionmember are medially biased outwardly away from the longitudinal axis ofthe bore towards an outer wall of the upper region of the bore, whichincreases the effective inner diameter of the upper region of the bore.Thus, it is contemplated that the illustrated embodiments provide ameans for engaging portions of the edge portion of the at least oneretention member thereby medially biasing portions of the at least oneretention member away from the longitudinal axis of the bore towards anouter wall of the upper region of the bore increasing the effectiveinner diameter of the upper region of the bore.

In one aspect, the retention system can comprise at least one retentionmember having an outer edge. In another aspect, the at least oneretention member can be a resilient, continuous, ring-shaped member inthe first relaxed position. As can be appreciated, the at least oneresilient retention member can have spring constant K_(R). As also canbe appreciated, it is contemplated that the at least one continuousring-shaped member can be circular, oval, elliptical, square, u-shaped,rectangular, or any other continuous geometric shape.

In one embodiment, a first retention mechanism 270 is provided thatcomprises a ring-shaped retention member 272, such as illustrated inFIGS. 2A-2E. The ring-shaped retention member, in one aspect, issubstantially elliptical in its relaxed position, such as shown in thetop plan view of FIG. 2B. The first retention mechanism 270, in oneaspect, comprises a cavity 276 formed therein the plate 152, which isconfigured for receiving the ring-shaped retention member 272. Thecavity can be substantially planar and substantially circular in theplane (illustrated in FIG. 2B) and can define a plane that issubstantially parallel to the anterior surface 152 a of the plate. Thecavity can be formed to extend inwardly into the plate from an upperportion of the bore 154, above the seat 156 of the bore, such as shownin FIG. 2C. Thus, when a retention member is inserted therein thecavity, and a bone screw 160 is operatively placed therein the bore, theretention member is positioned proximate, but above the upwardly facingshoulder 164 of the bone screw.

When a bone screw 160 is positioned therein the bore 154, portions ofthe retention member 272 will extend across portions of the shoulder 164of the bone screw, thereby preventing the bone screw from unseating orbacking out of the bore. It is contemplated that the ring-shapedretention member will be of a selected shape such that it will remain inthis relaxed, retaining position absent any shear or lateral forcesbeing applied to it. To access the bore (i.e., to insert or remove abone screw), a physician can use a driver/removal tool in combinationwith a bone screw removal device (as described further herein below) toflex the retention member 272 into a more rounded, open position. Forexample, as shown in FIGS. 2B and 2D, the portions of the ring-shapedretention member that extend across the shoulder 164 of the bone screwcan be flexed or forced outwardly toward the cavity 276 until they nolonger extend across the shoulder of the bone screw. One skilled in theart will appreciate that, when the retention member is biased into theopen position (FIGS. 2D and 2E), the bone screw can be removed. In afurther aspect, it is contemplated that means can be provided to preventthe ring-shaped retention member from rotating within the cavity,particularly when it is being flexed to access the bone screw.

In another embodiment, a second retention mechanism 570 is provided thatcomprises a substantially rectangular retention member 572 having, in afirst relaxed position, four substantially straight sides, such asillustrated in FIGS. 3A-3C. At least one side of the rectangularretention mechanism, in its relaxed (unstressed) positions, can extendacross a portion of the shoulder of a respective bone screw. In afurther aspect, two opposing sides of the rectangular retentionmechanism can extend across portions of the shoulder of the respectivebone screw, such as shown in FIG. 3B. In order to access the bone screw,the opposing sides can be flexed or stressed outwardly into an arcuateshape until the bone screw is unobstructed, such as shown in FIG. 3C. Itis contemplated that the other two opposing sides will be drawn towardeach other and can remain substantially straight as the retaining sidesare bowed outwardly. A cavity 576 can be formed therein the plate toreceive and retain the rectangular retention member. The cavity can besubstantially planar in a plane that is substantially parallel to theanterior surface of the plate. The cavity can be formed to extendinwardly into the plate from an upper portion of the bore, above theseat of the bore. The retention 272 member can have a centering featureconfigured to interact with a feature in the recess 576 to aid inmaintaining the orientation of the retention member. Such a cavity canbe similar to that shown in FIG. 2C, although it can be sized and shaped(i.e., rectangular, circular, etc.) to receive and accommodate therectangular retention member in its first relaxed position and secondstressed or flexed position.

According to another aspect, a third retention mechanism 670 is providedthat comprises a rectangular dual retention member 672, such asillustrated in FIGS. 4A-4C. In one aspect, the dual retention member isconfigured to be positioned between opposing bores. Opposing sides ofthe retention member are configured to extend across portions of theopposing bores. For example, as illustrated in FIG. 4B, in one aspect, afirst side extends across a portion of a first bore, and a second,opposing side extends across a portion of a second bore. Thus, it iscontemplated that a single rectangular dual retention member 672 can beused to secure at least two bone screws therein respective bores. Intheir first, relaxed position, the first and second sides of theretention member extend across the bores to retain the bone screwstherein. In order to access the bone screw, the first and second sidescan be flexed or stressed inwardly into an arcuate shape, eithersimultaneously (as shown) or one at a time until the respective bonescrews are unobstructed, such as shown in FIG. 4C. As the first andsecond sides are flexed inwardly, it is contemplated that the othersides will be drawn toward each other and can remain substantiallystraight. A cavity 676, such as that shown in FIGS. 4B and 4C can beformed therein the plate to receive and retain the rectangular dualretention member 672. As may be appreciated, the cavity can be sized andshaped to receive and retain the retention member. Additionally, it iscontemplated that the at least one elastically deformable retentionmember can be positioned therein each at least one cavity such that acenter of the at least one retention member is substantially stationarygeometrically when the at least one retention member is in the firstrelaxed position and the second expanded position. This may require theuse of a centering feature in the spring member, which may be kept inorientation by a feature in the plate within the recess 676.

In still another aspect, a fourth retention mechanism 770 is providedthat comprises an elastically deformable retention member 772 with abody 774 and two legs extending therefrom the body, as shown in FIG. 15.In this aspect, the two legs 790 have edge portions 791 of which atleast a portion is positioned within the retention member cavity 776such that portions of at least one of the legs 790 extend into the upperregion of the bore 154 within which it resides. As with the otheraspects, at least one of the legs are moveable between the first relaxedposition and the second expanded position. In the relaxed position, aportion of the edge portion of at least one of the legs extends inwardlysubstantially transverse to and toward the longitudinal axis of the boreand into its upper region, which decreases the effective inner diameterof the upper region of the bore and restricts outward movement of a bonescrew positioned within the bore. In the expanded position, portions ofat least one of the legs are medially biased outwardly away from thelongitudinal axis of the bore towards an outer wall of the upper regionof the bore, which increases the effective inner diameter of the upperregion of the bore. As can be appreciated, in the second expandedposition, a bone screw positioned within the bore can enter or exit thebore. Correspondingly, in the relaxed position, a bone screw positionedwithin the bore is substantially prevented from exiting the bore.

In one exemplified aspect, the retention member is secured to the plateat or near a portion of the body of the retention member. In one aspect,a portion of the body of the retention member defines a retention bore780 through which a retaining pin 785 may be positioned. In thisfashion, a portion of the plate defines at least one pin bore 788configured for positioning the retaining pin therein and therethroughthe retention bore, thereby affixing a portion of the body of theretention member to a portion of the plate. In yet another aspect, thebody portion of the retaining pin may be integral therewith the body. Inthis aspect, the pin bore would comprise a slot open into the upperregion of the bore.

According to various aspects of the present invention, a bone screwremoval device is provided for removing bone screw(s) from a bone screwretention system, such as the exemplary bone screw retention systemsdescribed herein. If desired and as may be appreciated, the bone screwremoval device can also be used to insert a bone screw into a bone screwretention system.

A bone screw removal device 100 according to one aspect comprises anouter sleeve and an inner sleeve sized and shaped to be received withinthe outer sleeve. In one aspect, the outer sleeve 102 comprises asubstantially cylindrical and hollow body, such as shown in FIG. 5B,that has an upper end and an opposing lower end. An inner sleeve 110 canhave a substantially cylindrical, hollow body with a respective upperend and an opposing lower end. The inner sleeve defines a conduittherein the body. A flange 112 can be provided at the upper end of theinner sleeve, the flange having a larger diameter than the diameter ofthe cylindrical body, such as illustrated in FIG. 5A. It is contemplatedthat the inner diameter of the outer sleeve is greater than the outerdiameter of the inner sleeve.

An inner sleeve 110, in one aspect, has a resilient tongue member 114that extends longitudinally down a portion of the body of the innersleeve. In one aspect, an upper portion of the tongue member is definedby a portion of the body of the inner sleeve. In a further aspect, theupper portion of the tongue member can be spaced at a predetermineddistance from the flange 112, such as illustrated in FIG. 5A. As can beappreciated, the tongue member can be a leaf spring having a springconstant K_(T). A lower portion of the tongue member 114 can furthercomprise a protrusion 115 that extends outwardly from the lower portion.In one aspect, the protrusion can be generally rectangular in shape;optionally and without limitation, the protrusion can be any othershape, such as semi-circular, partially circular, semi-elliptical,partially elliptical, triangular, or other shape.

According to a further aspect, one or more longitudinal guide slots 116can be formed in a portion of the body of the inner sleeve 110, such asshown in FIGS. 7A and 7C. Thus, the guide slot(s) can be formedsubstantially parallel to a longitudinal axis of the substantiallycylindrical body of the inner sleeve. In a particular aspect, a pair ofopposing longitudinal guide slots can be formed in the body, such thatthey are positioned approximately 180 degrees apart within the body ofthe inner sleeve. In a further aspect, the guide slots can berespectively positioned approximately 90 degrees from the center of thetongue member. The guide slots can be formed as open slots that extendfully through the side wall of the inner sleeve. Optionally, the guideslots 116 can be of a predetermined depth and do not extend fullythrough the side wall, such as shown in FIG. 7A. In yet a furtheraspect, the guide slots can extend longitudinally for a predetermineddistance along the body, the predetermined distance being less than thetotal height of the body. Thus, as shown in FIGS. 7A and 7C, the guideslot(s) 116 can begin at a spaced distance from the flange 112 andextend longitudinally to a spaced distance from the lower edge of theinner sleeve. As will be explained further below, the guide slot(s) areconfigured to receive a projection 106 of the outer sleeve 102.

One or more openings, or notches, 104 can be defined in the lower end ofthe outer sleeve. In one aspect, the opening can be a substantiallyrectangular notch, such as shown in FIG. 5B. Optionally, the notch canbe semi-circular, partially circular, semi-elliptical, partiallyelliptical, triangular, or any other shape. In a further aspect, thenotch 104 can be sized and shaped to receive at least a portion of theprotrusion 115 of the tongue member 114. Thus, in one exemplary aspect,the protrusion can be substantially rectangular and the notch has acomplementary rectangular shape to operatively receive the protrusion.

The outer sleeve 102 can further comprise longitudinal projections 106that extend inwardly from the inner wall of the outer sleeve. In oneaspect, the projections are substantially parallel to the longitudinalaxis of the substantially cylindrical outer sleeve. The projections canbe positioned approximately 180 degrees from each other along the innerwall of the outer sleeve. In a further aspect, the projections can berespectively positioned approximately 90 degrees from, on either sideof, the center of the notch 104. The projections, in one aspect, extendonly partially along the inner wall of the outer sleeve. Thus, asillustrated in FIG. 7A for example, the projection(s) 106 can begin at aspaced distance from an upper edge of the outer sleeve, and can end at aspaced distance from a lower edge of the outer sleeve. In one aspect,the length of each of the projections 106 is less than the length of theguide slots 116 of the inner sleeve. The projections can be, forexample, from 25 to 75% of the length of the guide slots. It iscontemplated that the projections are sized, shaped and positioned to bereceived by the guide slots of the inner sleeve.

As may be appreciated, in various aspects, a single retention member canbe provided within each bore to retain a bone screw therein. Optionally,two or more retention members can be provided to retain a bone screwtherein a respective bore. Similarly, bone screw removal devices can beprovided that have the ability to displace single retention members, aswell as dual (or more) retention members. For example, in a bone screwretention system in which a single retention member is used to retaineach bone screw, a bone screw removal device having a single tonguemember and protrusion, such as shown in FIGS. 5A-5B, 6, and 7A-7C, canbe provided. Optionally, a dual bone screw removal device (i.e., havingdual opposing tongue members) such as shown in FIGS. 8A-8C can beprovided, although it is contemplated that only one tongue member willbe needed to displace the single retention mechanism. Likewise, in abone screw retention system having two or more retention membersretaining each bone screw, a bone screw removal device having at leasttwo tongue members can be provided.

In use, the inner sleeve 110 is positioned therein the outer sleeve 102with the projections 106 inserted into respective guide slots 116 suchthat the tongue member 114 and protrusion 115 are longitudinally alignedwith the notch 104 of the outer sleeve. As illustrated in FIG. 7A, inone aspect, the projections are formed within the outer sleeve at apredetermined position to allow the inner sleeve to move from andbetween a first position in which the flange 112 is spaced from theupper edge of the outer sleeve (FIG. 7A, left), to a second position inwhich the flange substantially abuts the upper edge of the outer sleeve(FIG. 7A, right). As may be appreciated, when in the first compressedposition, the tongue member 114 is pushed inwardly toward the innerportion of the inner sleeve, such as shown in FIG. 7B, due to thepresence of the protrusion 115 at the distal end of the tongue member.As the inner sleeve is moved toward and to the second relaxed position,the resilient forces of the tongue member can urge the protrusion toextend into the notch 104 of the outer sleeve 102. In one aspect and asshown in the figures, in the second relaxed position, the at least oneprotrusion engages an outer edge of the edge portion of the at least oneretention member of the retaining system. Optionally, in the secondrelaxed position, the at least one protrusion engages an inner edge ofthe edge portion of the at least one retention member.

In one aspect, when the protrusion fully extends into the opening, suchas when the inner sleeve is in the second position, the tongue memberextends longitudinally at an angle substantially parallel to thelongitudinal axis of the tongue member. In a further aspect, theprotrusion can comprise an upper surface and an opposing lower surfaceseparated therefrom the upper surface by a front surface of theprotrusion. As illustrated in FIG. 9, in one aspect, the upper surfacecan taper downwardly toward the front surface of the protrusion so thatas the inner sleeve is moved from the first to the second position, theprotrusion can progressively ease into the notch 104.

As illustrated in FIGS. 9-12, in use, an exemplary bone screw removaldevice can be used to remove a bone screw from a bone retention system.A removal device can be placed within a bore 154 of an exemplary bonescrew retention system until the lower surface of the outer sleevesubstantially abuts or rests on the shoulder 164 of the bone screw 160positioned therein the bore. It is contemplated that when the outersleeve is positioned within the bore, the inner sleeve is in a firstposition in which the flange 112 is spaced from the upper edge of theouter sleeve. The outer sleeve can be positioned within the bore suchthat an opening or notch 104 of the outer sleeve is positioned over aretention member of the bone screw retention system. Thus, therespective retention member may extend into the inner portion (i.e., theconduit) of the outer sleeve via the respective notch. For example, asshown in FIG. 12, an exemplary bone screw removal device 200 can be usedto remove a bone screw 160 retained by a rectangular retention member572. The bone screw removal device, thus, can have a pair of opposingnotches 204 a and 204 b extending upwardly from the lower surface of theouter sleeve.

The removal device can be positioned within the bore such that each ofthe openings 204 a and 204 b is positioned over a respective side of therectangular retention member 572 a and 572 b. It is contemplated thatthe openings can be sized and shaped to receive the retention members.As shown in FIG. 12, when the outer sleeve is positioned therein thebore, the retention members extend inwardly toward the inner conduit ofthe outer sleeve. After the outer sleeve is positioned within the bore,the inner sleeve can be moved from the first position to a secondposition in which the flange substantially abuts the upper edge of theouter sleeve. As the inner sleeve is moved toward the second position,each of the protrusions 215 a and 215 b can extend into the respectiveopenings 204 a and 204 b. As described above, the upper surfaces of theprotrusions may taper downwardly toward the front surfaces of theprotrusions, such that the protrusions can progressively ease into theopenings as the inner sleeve is lowered. As the protrusions enter theopenings, the front surfaces can engage the respective retentionmembers. As can be appreciated, in one embodiment, if the springconstant K_(T) of the tongue members is greater than the spring constantK_(R) of the retention members, as the inner sleeve is moved completelyto the second position, as shown in FIG. 12, the retention members willbe laterally pushed outwardly away from the longitudinal axis of thebore by the protrusions, to a position in which they no longer cover orretain the bone screw. The progression of the inner sleeve from thefirst position to the second position is also illustrated in FIG. 11.

In another embodiment, a removal tool 140 can be inserted into theremoval device via the conduit of the inner sleeve. Exemplary removaltools can comprise screwdrivers having a head that mates with a portionof the head of the bone screw, or other tools known in the art. In oneaspect, a removal tool can be configured to engage the at least onetongue member, thereby urging the protrusion of the at least one tonguemember laterally outwardly away from the longitudinal axis of the bore,such as shown in FIG. 13. Thus, even if the spring constant K_(T) of theat least one tongue member is not greater than the spring constant K_(R)of the at least one retention member, a distal portion of the removaltool can engage the at least one tongue member and push at least onetongue member, and therefore, the at least one protrusion laterallyoutwardly away from the longitudinal axis of the bore, which also pushesthe at least one retention member laterally outwardly away from thelongitudinal axis of the bore to a position in which the at least oneretention member no longer covers or retains the bone screw.

With the inner sleeve in the second position (and with the retentionmember(s) no longer retaining the bone screw), the physician or surgeoncan use the removal tool to unscrew the bone screw and thus remove itfrom the bore. As shown in FIG. 11 (far right), as the bone screw isremoved from the bore, it moves upward. Because the outer sleeve restson a portion of the shoulder 164, as the bone screw moves upwardly, theremoval device moves upwardly. Due to the tapered shape of the head ofthe bone screw, the retention member can slide or ease into its relaxed,unflexed position as the bone screw is removed. After use, the bonescrew removal device can be reused. A physician can manually press theprotrusion(s) inwardly and then slightly upwardly so that the innersleeve can be returned to its first position.

FIGS. 14A-14D illustrate another exemplary bone screw removal device300. The bone screw removal device can comprise a main sleeve 302 thatis substantially cylindrical and defines a conduit therein. In a furtheraspect, the main sleeve has an upper surface and an opposing lowersurface. The main sleeve can define one or more openings 304 extendingupwardly from the lower surface of the main sleeve. In another aspect,the removal tool main sleeve 302 can be placed over the screw head suchthat the body portion of a retention member is recessed within theaperture in the removal tool. Rotation of the removal tool in thisaspect acts to displace the body of the retention member outwardlyrelative to the screw head, thus allowing screw removal. The removaldevice 300 can further comprise a removal sleeve 320 comprising a bandportion 322 that is substantially cylindrical and has a diameter greaterthan a diameter of the main sleeve 302. The removal sleeve can furthercomprise a tongue member 324 that extends downwardly from the bandportion. As shown in FIG. 14C, in one aspect, in its resting (i.e.,unstressed) position the tongue member extends downwardly from the bandportion at an angle that is less than 90°. For example, the tonguemember can be at an angle of between 45° and 90°. In a further aspect,the tongue member can be at an angle of between 75° and 90°, such as85°. The removal sleeve 320 can be positioned around the main sleeve 302with the tongue member 324 extending downwardly over the opening 304. Inthis position, the tongue member can extend inwardly into the mainsleeve via the opening, such as shown in FIG. 14C (resting position).

In a further aspect, the removal sleeve can be removably attached to themain sleeve. For example, in one aspect, one or more indentations can beformed within the exterior surface of the main sleeve. The band portionof the removal sleeve can have protrusions extending inwardly from itsinner surface. The protrusions can be sized, shaped and positioned to bereceived by the indentations of the main sleeve when the removal sleeveis placed around the main sleeve. Thus, the removal sleeve can snap intoa desired position for use. In a further aspect, the indentation(s) canbe substantially round, such as, without limitation, hemispherical,partially spherical, etc. The protrusion(s) can be similarly shaped tobe received by the indentation.

Optionally, a circumferential groove can be formed on the main sleevethat can be sized and shaped to receive the band portion of the removalsleeve. Thus, the groove can have a height that is slightly greater thanthe height of the band portion, and can have a predetermined depthsufficient to receive the band portion and substantially prevent it frommoving (i.e., up or down) when it is in use. In another aspect, aplurality of circumferential flanges can be formed on the main sleeve.The flanges can be spaced at a predetermined distance from each otheralong the main sleeve such that the band portion of the removal sleevecan be received and secured therebetween. In yet another aspect, theremoval sleeve can be fixedly attached to the main sleeve in apredetermined position.

The bone screw removal device 300 can be used by a physician to remove abone screw from a bone screw retention system. The main sleeve 302 canbe positioned within a bore, such that the main sleeve rests on theshoulder of the bone screw. As described above, the main sleeve can bepositioned therein the bore such that the opening or notch 304 ispositioned over a respective retention member, allowing the retentionmember to extend inwardly into the main sleeve via the opening. Aremoval tool can be inserted into the conduit of the main sleeve toremove the bone screw. As the tool is inserted therein the main sleeve,it is contemplated that it can contact the tongue member and thus forcethe tongue member to its in-use position (FIG. 14D). As the tonguemember is forced or moved to its in-use position, it will consequentlymove the respective retention member to a position in which it no longerobstructs or retains the bone screw, and the bone screw can be removed.It is contemplated that the exemplary bone screw removal device 300 cancomprise more than one opening, and more than one tongue member, suchthat multiple retention members of the bone screw retention system cansubstantially simultaneously be moved to non-retaining positions.

According to various aspects, various components of a bone screwretention system and bone screw removal device can be formed from abiocompatible, flexible material such as, but not limited to,shape-memory alloys, titanium alloy and the like as disclosed in U.S.Pat. Nos. 4,857,269 and 4,952,236, which are incorporated in theirentirety herein by reference. Further, polymeric materials such as, forexample, ultra-high molecular weight polyethylene can also be used toform various components of the bone screw retention and removal system.Such exemplary materials can be used, for example, to form the exemplaryretention members described above. The materials can also be used toform the tongue members of the various bone screw removal devicesdescribed above. In yet another aspect, such materials can be used toform all of the components of the exemplary bone screw removal devicesdescribed above. The plate itself can comprise any biocompatiblematerial such as titanium, titanium allow, stainless steel, PEEK (PolyEther Ether Ketone), and the like

It will be apparent to those skilled in the art that variousmodifications and variations can be made in the present inventionwithout departing from the scope or spirit of the invention. Otherembodiments of the invention will be apparent to those skilled in theart from consideration of the specification and practice of theinvention disclosed herein.

1. A bone screw retention system for retaining bone screws therein, andreleasing bone screws therefrom, comprising: a plate that defines aplurality of transversely extending bores configured for receiving bonescrews and at least one retention member cavity corresponding to eachbore, each bore having a longitudinal axis, wherein portions of theplate define at least one transversely extending pin bore extending froma portion of the retention member cavity; at least one elasticallydeformable retention member positioned therein each retention membercavity, the elastically deformable retention member comprising: a bodyhaving two legs extending therefrom the body, wherein portions of atleast one of the legs extend into an upper region of the bore; aretaining pin extending substantially perpendicular to the longitudinalaxis of the bore configured for receipt into the pin bore to affix atleast a portion of the body to a portion of the plate, wherein, when theretaining pin is positioned therein the pin bore, the body issubstantially restricted from moving toward the longitudinal axis; andwherein a portion of the at least one leg is movable between a firstrelaxed position and a second expanded position, wherein, in the firstrelaxed position, a portion of the at least one leg extends inwardlysubstantially transverse to and toward the longitudinal axis of therespective bore and into the upper region of the bore, which decreasesan effective inner diameter of the upper region of the bore, andwherein, in the second expanded position, portions of the at least oneleg are medially biased outwardly away from the longitudinal axis of thebore towards an outer wall of the upper region of the bore, whichincreases the effective inner diameter of the upper region of the bore,permitting a bone screw positioned within the bore to exit the bore, andin the first relaxed position, a bone screw positioned within the boreis substantially prevented from exiting the bore by portions of the atleast one leg.
 2. The bone screw retention system of claim 1, whereinthe retaining pin is integral therewith the body.
 3. The bone screwretention system of claim 1, wherein the pin bore is a slot open intothe upper region of the bore.
 4. The bone screw retention system ofclaim 1, wherein the at least one elastically deformable retentionmember comprises a plurality of elastically deformable retentionmembers.
 5. The bone screw retention system of claim 1, furthercomprising a means for engaging portions of the two legs of the at leastone retention member thereby medially biasing portions of at least oneof the legs away from the longitudinal axis of the bore towards an outerwall of the upper region of the bore increasing the effective innerdiameter of the upper region of the bore.
 6. A bone screw retentionsystem for retaining bone screws therein, and releasing bone screwstherefrom, comprising: a plate that defines a plurality of transverselyextending bores configured for receiving bone screws and at least oneretention member cavity corresponding to each bore, each bore having alongitudinal axis, wherein portions of the plate define at least onetransversely extending pin bore extending from a portion of theretention member cavity; at least one elastically deformable retentionmember positioned therein each retention member cavity, the elasticallydeformable retention member comprising: a body defining a retention boretherethrough and having two legs extending therefrom the body, whereinportions of at least one of the legs extend into an upper region of thebore; a retaining pin configured to be positioned therethrough theretention bore and into the pin bore, thereby affixing a portion of thebody of the retention member to a portion of the plate, wherein, whenthe retaining pin is positioned therein the pin bore, the body issubstantially restricted from moving toward the longitudinal axis; andwherein a portion of the at least one leg is movable between a firstrelaxed position and a second expanded position, wherein, in the firstrelaxed position, a portion of the at least one leg extends inwardlysubstantially transverse to and toward the longitudinal axis of therespective bore and into the upper region of the bore, which decreasesan effective inner diameter of the upper region of the bore, andwherein, in the second expanded position, portions of the at least oneleg are medially biased outwardly away from the longitudinal axis of thebore towards an outer wall of the upper region of the bore, whichincreases the effective inner diameter of the upper region of the bore,permitting a bone screw positioned within the bore to exit the bore, andin the first relaxed position, a bone screw positioned within the boreis substantially prevented from exiting the bore by portions of the atleast one leg.
 7. The bone screw retention system of claim 6, whereinthe at least one elastically deformable retention member comprises aplurality of elastically deformable retention members.
 8. The bone screwretention system of claim 6, further comprising a means for engagingportions of the two legs of the at least one retention member therebymedially biasing portions of at least one of the legs away from thelongitudinal axis of the bore towards an outer wall of the upper regionof the bore increasing the effective inner diameter of the upper regionof the bore.